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Two genes associated with breast cancer, BRCA1 and BRCA2, were discovered in 1994 and 1995, respectively, and shortly thereafter, were patented by Myriad Genetics, a company based in Utah. Under the patents, testing for mutations in these genes could only be performed by Myriad, at costs from $300 to $3,000. Myriad also patented the process of analyzing the results of such tests, preventing anyone who obtains the sequence of their BRCA genes by other means (which itself would probably be patent infringement) from interpreting the information.
The idea that genes can be patented has been a contentious issue from the beginning. Patents are not granted for products of nature, meaning that genes inside the body are not patentable, but biotech companies successfully argued that by removing a gene from the human body, purifying it, and then obtaining its DNA sequence, they created something not found in nature, and which is therefore a patentable invention. The U.S. Patent Office found the argument persuasive, but opponents argue that genes are parts of our bodies and can be identified but not invented. Biotech companies argue that without the protection offered by patents, they would have no incentive for research and development of diagnostic tests.
In Europe, patents for BRCA1 and BRCA2 were revoked in 2004 because they did not meet the standards for a patent. After more than a decade of legal disputes, the patents were partially restored in 2008 on a very restricted basis. In the United States, a lawsuit, focused on the patents for the BRCA genes, was filed in May 2009. The suit challenges the basic idea that genes are patentable. In November 2009, the judge ruled that the lawsuit can proceed, and the case is moving forward. In March 2010, a federal court invalidated Myriad Genetics’ patent on these genes. In August 2011, the U.S. Court of Appeals reversed the lower court’s decision and ruled that gene sequences isolated from cells are not a product of nature and are therefore patentable. The case went to the U.S. Supreme Court, which ordered the appeals court to reconsider the case. The Federal Appeals Court did not change its decision, and the case once again, went to the U.S. Supreme Court. A unanimous decision in June 2013 invalidated Myriad’s patents on the basis that isolating a gene from nature does not make it patentable. This is a landmark decision on gene patenting with widespread ramifications for the biotechnoloogy industry.
Will this decision reduce the incentives for companies to invest in new diagnostic tests that would be used by cancer victims or those with serious genetic disorders?
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Chapter 8 Solutions
Human Heredity: Principles and Issues (MindTap Course List)
- Although it is well known that X-rays cause mutations, they are routinely used to diagnose medical problems, including potential tumors, broken bones, and dental cavities. Why is this done? What precautions need to be taken?arrow_forwardOn the image, you can see the results of a DNA microarray used for cancer prognosis, where tissue samples from healthy and cancerous tissues were analyzed. cDNA from healthy cells and cancer cells were labeled with green and red fluorescence, respectively, mixed equally, and hybridized with the chip. It is known that gene A is more highly expressed in breast cancer type I, while genes B and C have lower expression in type II, which is highly aggressive. Based on the gene expression levels shown in the image, the cancer sample does not correspond to either type I or type II breast cancer, why is that?arrow_forward1. a) If you were at risk of a fatal disease such as Huntington’s disease and only the 95% accurate preliminary genetic test was available, would you take the test? After all, 95% of the time the test would tell you whether you would eventually get Huntington’s disease or whether you did not have to worry about getting this disease. b) The linkage distance between the DNA sequence used in the test and the actual Huntington’ disease locus was 5%. In a large sample of the Venezuelan family, what percentage of people would inherit the DNA sequence but not the Huntington’s allele (i.e. be a false positive test for Huntington’s)? What percentage of that large Venezuelan family would not inherit the DNA sequence but would inherit the Huntington’s allele (i.e., be a false negative test for Huntington’s)?arrow_forward
- (2) Design an experiment on how would molecular genetic tools, such as DNA microarrays, be used to study human diseases, such as skin tumor cell growth or migration? How could they be used to study melanin expression in nomal skin cells? Rubric for Class Portfolio #1: Student creates an experiment with experimental and negative control group on hoW DNA microarrays can used to address how it can be used to monitor skin tumor cell growth and/or migration, as well as melanin gene expression.arrow_forwardWhile a stem cell transplant from an unaffected donor is currently the only cure for DBA, genome-editing technologies may one day enable the correction of a mutation in a patient’s own bone marrow stem cells. However, what specific information would be needed, beyond a symptom-based diagnosis of DBA, in order to accomplish this?arrow_forwardGive a schematic diagram of how we can Treatment Down's syndrome by using gene therapy? Please answer at your own words,please..arrow_forward
- Cystic fibrosis (CF) is a genetic disorder affecting a number of organs, including the lung airways, pancreas, and sweat glands. Mutations in both copies of the CFTR gene causes cystic fibrosis. Imagine that you have sweat gland samples from several Cystic Fibrosis patients (A-C) with unknown mutations in CFTR. You also have normal (+) sweat gland sample to use as a positive control. А В С А В С Choose which mutation would explain the RNA and protein results in A, B, & C: 1. Promoter/Regulatory mutation 2. Silent mutation 3. Missense mutation 4. Deletion mutation 5. Splice site mutation 6. Nonsense mutation RNA gel Protein gelarrow_forwardResearchers have identified a gene in humans that (when mutated) causes tremors and unstable walking due to neurological problems. This disorder is inherited in an autosomal recessive manner, and the mutant allele isknown to result from a loss-of-function mutation. The same gene hasbeen found in mice, although a mutant mouse version has not beendiscovered. To develop an effective drug therapy to treat this disorderin humans, it would be experimentally useful to have a mouse model.In other words, it would be desirable to develop a strain of mice thatcarry the mutant allele in the homozygous condition. How would youdevelop such a strain?arrow_forwardScientists carried out a microarray analysis to compare the gene expression of normal pancreatic cells to that of cancer cells from a person with pancreatic cancer. The scientists labeled the cDNA from the normal pancreatic cells with green fluorescent nucleotides. They labeled the cDNA from the cancer cells with red fluorescent nucleotides. The two cDNAs were mixed and allowed to hybridize to a microarray. Less p53 activity is found in cancer pancreatic cells than normal cells. What color would the spot for the p53 gene be on the microarray? Red Green Yellow Blackarrow_forward
- Sarah has always lived what many consider an active and healthy lifestyle. She makes a conscious effort to eat well and exercise daily, never smoked, and drinks moderately. Many of Sarah's female relatives (including her mother and grandmother) have had breast cancer. Sarah has decided to have her genome sequenced. She is specifically interested in whether she shows mutations in BRCA1 and BRCA2 that are linked to breast cancer. What information can be drawn from the sequence data Sarah will receive? Justify your answer. • Sarah will know if she will develop breast cancer. • Sarah will know if and when she will develop breast cancer. • Sarah will know the severity of her breast cancer based on the number of mutations; that is, the more mutations in those genes, the greater the severity of the disease. • Sarah will know whether she is predisposed to breast cancer. • Sarah will know that she will not develop breast cancer if there are no mutations in those genes.arrow_forward2)You would expect liver cells and muscle cells to have the same gene expression. a)True b)Falsearrow_forwardGenetic tests that detect mutations in the BRCA1 and BRCA2 oncogenes are widely available. These tests reveal a number of mutations in these genes—mutations that have been linked to familial breast cancer. Assume that a young woman in a suspected breast cancer family takes the BRCA1 and BRCA2 genetic tests and receives negative results. That is, she does not test positive for the mutant alleles of BRCA1 or BRCA2. Can she consider herself free of risk for breast cancer?arrow_forward
Human Heredity: Principles and Issues (MindTap Co...BiologyISBN:9781305251052Author:Michael CummingsPublisher:Cengage Learning